European Court is on the Wrong Side on Patient Safety
Síle Lane from Sense About Science discusses the recent European Court injunction on clinical trial data.
The European General Court has issued an injunction to prevent the European medicines regulator from releasing information from clinical trials conducted by AbbVie and InterMune at the request of the two companies. While yesterday’s ruling pertains to two particular cases it has ramifications for all.
The Court’s decision puts the European Medicines Agency into conflict with its own policy, announced in 2012, to proactively release data from clinical trials supporting the authorisation of medicines being used by patients all over Europe. The Clinical Study Reports that EMA has made available since last year were one of the few ways that researchers could access otherwise withheld material. Their release was instrumental in spotting serious flaws in the evidence for Roche’s drug Tamiflu, for example, which the UK government alone spent £500m on in one year.
More importantly the Court’s decision at the request of AbbVie and InterMune puts it into conflict with the interests of patients. When GSK joined the AllTrials campaign and promised to publish all the CSRs available since its formation as a company they said that they owe this to the patients who have taken part in their trials. Two hundred other organisations including more than 100 patient groups and 50,000 people have signed up to the campaign calling on regulators worldwide to do everything they can to secure registration and publication of the results of clinical trials.
So we’re on the brink. Patients and researchers all over the world have started pushing for historic change. GSK has shown that it’s not beyond the reach of pharma companies to agree to that change. The EMA has tried going some way to delivering on that change.
But, EMA now has to decide if the European Court’s ruling will divert them from their policy to publish trial information. We will be sending the EMA the AllTrials petition. We will be asking them to continue their fight for transparency and showing them that tens of thousands of people are asking why they don’t have access to the evidence behind the medicines they use, prescribe and research. Will you help us today at www.alltrials.net? Please, ask your colleagues and friends to add their voices and ask them to forward this to others when they have.
The European Court has indicated that it is on the wrong side of history. The EMA now has to show that arguments in favour of secrecy no longer hold.
Síle Lane is director of campaigns at Sense About Science
I think this is seriously overdramatising things. The European Court is simply following the law, which is kind of what you’d hope a court would do.
While the action by AbbVie and InterMune is regrettable, and something that I’m sure all right-thinking people would wish to fail, the fact remains that it is a legitimate legal challenge, and must be allowed due process. That’s all the court ruling is about. Until the case is decided, it makes sense to keep their documents confidential, as they can always be released later if the action fails. It wouldn’t work the other way round.
I hope there is a swift resolution to this and that the ultimate judgement comes down on the side of transparency. But seriously, I would far rather that such decisions were made following proper legal process than simply following the whims of a few loud-mouthed activists.
We are on the brink of a breakthrough in access to trial data. Individual researchers have finally managed to unite and build momentum against big commercial and organisational behemoths with massive legal teams. We need to keep the campaign going, representing what is patients want, and now is the time to do just that.
I am in favour of publishing clinical trial data, have said so repeatedly in print and made a statement to this effect to the Parliamentary commission http://www.parliament.uk/documents/commons-committees/science-technology/Clinical%20trials%20combined.pdf (statement number 9) . However, your comment here is silly. You are confusing two things: the desirable conclusion and the process to be followed. To give an example to make the distinction clear, the fact that courts have intervened to prevent the deportation of Abu Qatada does not mean that the judges concerned approve of his politics. I would have thought that this was so obvious, it was not necessary to make the point. Apparently, it is. It seems that boasting that you have sense about science doesn’t mean you have sense about society.
My declaration of interest is here http://www.senns.demon.co.uk/Declaration_Interest.htm
I signed this petition because the U.S. has the same issues with marketing of pharmaceuticals and medical devices getting way ahead of scientific evidence of safety and effectiveness. Thousands of lawsuits by harmed patients from failed implanted metal-on-metal hips and vaginal surgical mesh are a horrendous indicator of this disconnect. No amount of money will restore these broken lives. The drive for profit cannot justify this lack of oversight. Transparent clinical trials and scrupulous post-market surveillance will prevent escalating healthcare costs and human suffering.
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I am in favour of publishing data for all clinical trials, whether positive or negative. I support transparency. The truth must come out, even it hurts. After all it’s a matter of public health. I extend my full support and cooperation.
I really wonder why you will refer to hose agitating for transparency as “loud mouthed activist”. They are entitled to make demands for transparencyn that doesn’t make them “loud mouthed”. A demand for accountancy and transparency is welcome.
We must not hide the facts of research from the public. Why do the EU think they have the right to be able to make this decision? This must be taken further and their decision questioned for the good of all our futures.